Regulatory Affairs Device Manager (m/f/d), Kundl, Austria; Holzkirchen, Germany; or Cambridge, UK
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
Your key responsibilities:
The Regulatory Affairs Device Manager (m/f/d) role is embedded in the Global Regulatory Affairs Department at Sandoz Biopharmaceuticals. In this role you will be responsible for delivering and maintaining global compliance and regulatory approval of medical devices which range from simple drug administration tools to complex needle injection systems and on-body devices.
This position can be based either in Kundl, Austria; Holzkirchen, Germany; or Cambridge, UK, depending on the location of the candidate.
Your responsibilities include, but are not limited to:
• Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of Notified Body Opinion interactions
• Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone devices.
• Supports audit readiness activities and medical device inspections including obtainment and maintenance of certification for stand-alone devices
• Regulatory lead for the development / manufacture of medical devices, including management of relevant registration, certification, and audit requirements. Operational owner of medical device related deliverables and timelines
• Support the generation and maintenance of design history files and review these documents during development and post-marketing, respectively
• Liaise, as core member of the device development team, with other functions of medical device development to define and achieve the aligned strategy
• Support of regulatory intelligence (legislation and trend review) and contributions to continuous improvement of submission process, templates and knowledge transfer within project teams
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• Advanced University degree or equivalent education/degree in life science/healthcare is required (minimum requirement Masters degree or equivalent)
• 3-5 year industry experience working in medical device development or registration with a solid grasp of relevant regulations and standards including MDR 2017/745, 21 CFR 820 / 21 CFR 4, ISO 13485 and ISO 11608
• Experience in the generation or review of Clinical Evaluation Protocols and Reports for medical device submissions
• Experience in the generation of the technical file for stand alone device submission and experience in the generation of Notified Body Opinions or relevant CTD modules for combination products including module 3 sections P2.4, P3.5 and P7
• Fluent in English (oral and written) - with excellent verbal and written communication skills
• Attention to detail and quality focused
• Highly collaborative team player with ability coordinate deliverables cross-functionally
• Experience leading teams and topics and within area of expertise in a matrix environment
• High change agility - ability to adapt quickly & effectively in a dynamic environment.
• Proactively / independently engages with internal and external stakeholders.
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities.
For Austria: In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.212,18 (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/network